Miconazole Nitrate

INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.

DOSAGE AND ADMINISTRATION Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.

CONTRAINDICATIONS Patients known to be hypersensitive to this drug.

ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1 . 3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence. The therapy-related dropout rate was 0 . 3%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

DESCRIPTION Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, USP 1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C 18 H 14 Cl 4 N 2 O•HNO 3 ; the molecular weight is 479.14 and the structural formula may be represented as follows: 009711be-figure-01

​OVERDOSAGE Overdosage of miconazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 578 . 1, greater than 640, 275 . 9 and greater than 160 mg/kg, respectively.

HOW SUPPLIED Miconazole Nitrate Vaginal Suppositories USP, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator NDC 0472-1738-03. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 7/2020